Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide Mixed with IFA, IFA and IFN-alpha, IFA and IL-2, or IFA and GM-CSF for Patients with Digestive Cancer and Endocrine Organic Cancer (Phase I clinical study)
Phase 1
- Conditions
- Advanced or recurrent digestive cancer and Endocrine Organic Cancer
- Registration Number
- JPRN-UMIN000000905
- Lead Sponsor
- Department of Surgery, Sapporo Medical University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria
Not provided
Exclusion Criteria
Exclusion criteria included (1) the presence of other cancers that might influence the prognosis, (2) immunodeficiency or a history of splenectomy, (3) need of steroid therapy, (4) severe cardiac insufficiency, acute infection, or hematopoietic failure, (5) prior cancer therapy such as chemotherapy, radiation therapy, steroid therapy, or other immunotherapy within the past 4 weeks, (6) ongoing breast-feeding, and (7) unsuitability for the trial based on clinical judgment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of adverse effect
- Secondary Outcome Measures
Name Time Method Evaluation of immunological and clinical responses. Immunological responses were investigated by DTH, tetramer staining, and ELISPOT assay. Clinical responses were evaluated by RECIST criteria and change of tumor marker levels.